Category Archives: Quality

The Outputs of Design and Development Clause 8.3.5

In the previous post we touched upon the inputs for the Design and Development Clause of the  ISO 9001 standard. The outputs are closely related to the inputs of course, but they have some twists to them. The four outputs that need to be covered are:

  1. Meet the input requirements.
  2. Be suitable for subsequent processes for the provision of products and services.
  3. Include, or refer to, appropriate monitoring and measuring requirements and their acceptance criteria.
  4. Define the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

All the information of the Design and Development outputs needs to be documented either through a register or some other form.

Meet the Input Requirements

This one is pretty straight forward. The product should meet the input requirements. If the product or service doesn’t meet the requirements, it isn’t only useless, but we have also failed to fulfill our customer’s needs—a pretty important part of doing business. To meet the requirements, it is critical that these requirements were very clear in the first place. The clarity of the requirements should be well thought of during the input phase of the design and development process.

Be Suitable for Subsequent Processes for the Provision of Products and Services

The company should be able to have processes in place to realize the product or service according to the specs of the customer. These processes are part of the QMS and should lead to a desired output. It should be very clear that the QMS of the company is able to produce the product within specs and rules and regulations.

Include, or Refer to, Appropriate Monitoring and Measuring Requirements and Their Acceptance Criteria

The company needs to have a strong plan to monitor if the product is designed as expected. This can, of course, be accomplished by very close communication with the customers and other stakeholders in the process. The way the company communicates and how it documents this information should be clearly defined to make it unambiguous.

Define the Characteristics of the Products and Services That Are Essential for Their Intended Purpose and Their Safe and Proper Provision

The products or services should function as intended—this is also closely related to the input requirements. When these are pretty clear, it gets a lot easier to make the product or service function as intended. However, even if the requirements are clear, the company should fully understand if the product or service is safe and properly functioning. The customer can request a car without a steering wheel, but even if the company built such a car, it is mostly likely not safe and not intended to operate like this, except for a self driving car maybe. So even if the specs are clear, the company has the duty to judge if the functions are really what some can expect from the product or service. 

Documented Information on Design and Development Outputs Must Also Be Retained—IE: Records

Lastly, it is crucial to have all the information created during the processes documented in some way. This can be in Word/Excel documents or in specialized platforms. It should be retrievable whenever asked for by someone.

Conclusion

The 8.3.5 isn’t all that hard in essence, it just requires the company to make sure that the product is developed as intended by the stakeholders. The information that is created during the process should be registered in a system as per the company’s choice. 

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Bring your quality & safety inspections to the next level

Filling out paper forms is very time-consuming. No one enjoys it, especially when it means a lot of extra work after forms are filled in. Usually the forms have to be checked and re-entered to the quality management system, which means hours of additional work every week—for nothing. Using pre-configured and custom mobile forms, your company can easily save hours of valuable time per inspection.

Analysis

It’s hard to monitor progress or draw conclusions from a stack of papers. Manually entering data into a spreadsheet or other document and creating reports is time-consuming and carries the potential for human errors, including inaccurate or omitted information.

On the other hand, digital forms are automatically uploaded into your quality management system, where it is compared to existing data. From there it’s easy to track progress, setbacks, health and safety concerns, and other significant events, allowing quality inspectors to easily create impactful reports.

Incident Reports

Digitizing the management system means that on average 30% more incident reports come in. The ease of use lowers the barriers because it makes it easy for employees to fill in digital forms during their inspection walks on their phone or tablet. Besides that, they also have the possibility to attach a picture with a description of the non-conformity. All these processes have been simplified so that incidents are actually reported.

Take Action

After you’ve collected data and identified a potential problem, it’s time to take action. Plan your corrective and preventive action in a proper manner and make them actionable. By directly assigning the action to the responsible person, it becomes much easier to manage the action that resulted from the inspection. With an online quality management platform you can easily track progress on the tasks and analyze their effectiveness.

Qooling

With Qooling, paper quality and safety inspections are history. The online solution offersyou a simple way to digitize your quality and safety inspections and reduce the dailyworkload. Log in from any location and have real-time insight into the work of your team, anytime and everywhere. Try it today!

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Change Management in Quality Management

The continuous improvement plans created have to be implemented properly to really add value. Coming up with the plan or idea is the easy part. Making sure the plan is fully implemented and supported by the organization is the hard part. To make a plan successful, change management is the key.

Personal Change

Most people resist change and prefer to keep working the way they are used to, regardless of the inefficiencies and struggles during their day-to-day activities. This means that the outcome of the plan comes down to psychology more than actual quality management. This makes it all the harder.

When an employee doesn’t see how the change improves their life, they simply tune out. In an organization this is very complex because of all the interactions. The small loss of time for one can be a huge time saver for the next. This setting makes it hard for people to accept the change because they don’t see the added value for them.

Organizational Change

When we look at the organizational level, change management starts to get very complex. As mentioned above, some people lose and others gain during this change. Certain employees need to do some additional work to make life easier for their colleagues down the hall. The problem is that the people that feel they lose something will resist relentlessly. This can harm the effectiveness of the project significantly. When someone doesn’t see the benefit instantly, it is crucial to show them the current situation and how the workload is divided among the different employees. Besides the workload, you can also show why things go wrong and put a dollar value on the issues that have been logged due to the problems

Also, mapping out the processes and showing the bottlenecks in the process is a great method to open the eyes of the employees. Even then, there will be a number of people that will resist the change. Top Management buy-in can become the key driver to convince the last set of people. When they support the project it will be a lot easier to make sure people move in the right direction.

Prevent Dead Projects

A lot of improvement plans get canceled due to the complexity that comes with change management. Employees don’t support or aren’t willing to change. Projected results are not reached due to poor change management and execution. This cannot be prevented all the time but certain things can be done to increase the likelihood of success.

Engagement

Engage key people in the project. Make them part of the project right when the project is still in the planning phase. When they are part of the project team they feel ownership and take responsibility during the implementation phase. This helps a lot to drive the change through the organization.

Communication

Clearly communicate the implications for the different roles in the company. Don’t sugarcoat it, when people have to do some additional work be upfront about it and show them why. This can be done by showing the actual data you have gathered on what goes wrong in the process. They will see why change is important when the losses are visual.

Use data

Use data to back-up your claims. Show the people how you came to a certain conclusion and why this change will have a positive effect on it. When you actually get the results you anticipated, make sure to celebrate it. This will give some credit for the next project and there will be a lot more in the future. 

A proper platform can be used as a guide during the change management project. An easy-to-use platform allows people to adopt the new situation more easily and the data coming out of it allows for instant proof why the new way of working is a step forward. Make sure the right solutions are in place to support your improvement projects.

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ERP is not your QMS

Yes, it might seem enticing, all your QMS information into your ERP. We can have all the information in one system, this will make it much easier for the employees. But is it really that simple?

With the ever-complexer environment and fast-changing landscape, is the single ERP approach really moving your company forward? Trying to fit everything into one ERP means that a company needs to cut back on a lot of functions and features. Most ERP solutions originated out of the founder expertise, this can be finance, logistics or HR. However, this also means that a lot of other functionalities simply too basic. Quality is 9 times out of 10 one of these lacking features in ERP. Most ERPs allows you to easily create a data table where you can key in your data- like an Excel sheet and for the more advanced ones, you will have some sort of workflow. But it is the interaction within the QMS that allows companies to really leverage the Management System. Plus the ERP becomes so complex that the adoption of your QMS is really jeopardized by this. This isn’t when the company  is on a path to Operational Excellence.

The connection

The ERP is the backbone of the IT infrastructure for a lot of companies. There is nothing wrong with that, but make sure you can integrate specialist solutions and platforms with it. Too often we talk to companies that have shielded on-premise solutions and therefore are unable to connect the solutions. In this case, consider switching to a connected SaaS solution because these silos can seriously harm the company. Connections and integrations allow you to really leverage data that is already gathered in other solutions like, for example, product data, supplier information, customer information, and employee information. The Quality Management Platform can than enhance this data with the information gather on the Quality Platform. This combination gives companies the possibility to create real enriched dossiers of products, customers, and suppliers. Also, it allows for NCR creation from within different platforms, which can then be synced with your Quality Platform for data consistency and real-time follow up.

Clarity leads to adoption

It may sound counterintuitive, but we have seen companies loving the approach of specialist platforms. They can simply tell their employees that everything related to Quality can be foundwhen you login on this platform. Setting up good user profiles results in a dynamic QMS basedon the role the employee has within the organization. Reducing the information based on the role increases the adoption of the platform and therefore the adoption of the QMS. Adoption is key for an effective QMS, which is needed when the company wants to reach Operational Excellence

Conclusion

Don’t try to fit the QMS in your ERP. Most ERP solutions aren’t build for this and will cost you a lot more than it gains. Make sure, however, that the ERP allows for integration with other solutions to streamline internal processes and prevent redundant work.

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How to Build a Quality Driven Culture

We have talked quite extensively about the importance of a good safety culture. It is essential to keep people safe at work and make sure everybody goes home healthy at the end of the day. However, the quality culture is just as important as the safety culture. There needs to be a healthy quality culture in order for the company to thrive.

It All Starts with Passion

Delivering the highest quality comes with a passion for the job. Whether you are a carpenter, banker, or quality manager, when you have a real passion for your job you will do the best you can. Hiring the right people can already prevent some quality problems. The employees form the culture and deliver the end product. Hiring people that don’t really care about the product or service you deliver can lead to some serious issues. Make sure you hire the right ones.

Trust your People

When you have hired the right people and trained them properly, it’s important to trust them. Too many companies have complete encyclopaedias full with procedures, work instructions, and detail step-by-step guides. The workforce simply have to follow these steps to get the products or services out the door. When these guides are too detailed, people won’t feel responsible for their job. They are caught in the processes and will always blame the system instead of looking at their own actions. Yes guidance is good, but try not to make it too rigid as people lose motivation and stop caring.

Feedback

Another great method to create a quality driven culture is feedback. Allow the employees to give feedback on the instruction the company has in place. The people performing the steps know exactly what is going on during the day-to-day operations. They have a feeling of the friction between the steps, so involve them as they hold a lot of valuable knowledge.

Within the same line of reasoning, give the employees feedback. When someone reported an NC, make sure you keep him/her involved and give active feedback. They will therefore feel engaged and see how the company uses his/her input to improve the organization. This will definitely engage the employees.

Platform

To support the culture, a proper quality Management Platform is a necessity. The easy access to the right information allows employees to conveniently interact with the management system. They can grab the right process right away without searching too long and create a NC or other issue by three simple clicks. Furthermore, they should be able to see the progress of the NC/Issue they filled in real time to keep them engaged. When you want to bring the quality culture to the next level, make sure a proper Quality Management Platform is in place.

Celebrate

Lastly, the most important point, celebrate goals. Make sure when quality goals are reached that you take a moment and celebrate them. Get lunch, grab a beer, or just get some cake to share around, but make sure you celebrate reaching goals. This way everybody can feel the excitement and become motivated to reach more goals.

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Key IT consideration When Selecting a New Quality Platform

Quality management is a key target for digital transformation, and while adoption of quality systems is growing, it’s important to address IT concerns before you make your final decision.

If you’re considering to invest in a quality management platform for your organization, it’s essential to think about the security, ease-of-use, and integration with other systems. Today we’re looking at each of these, so that you can make a well-considered choice.

Cloud vs. On-Premise

By 2020, Gartner expects that Software as a Service (SaaS) will officially surpass on-premise software solutions. The main reasons so many companies are opting for cloud, and SaaS inparticular, comes down to the total cost of ownership. Updates are part of the package and most of the time on a regular basis, so updating your system isn’t required anymore.

Easily Deployable

SaaS solutions are much faster to deploy than the on-premise solutions. Most SaaS solutions start right away without any requirements for installation. You simply login and are ready to go. This will cut deployment time by at least a couple of weeks, or even months, depending on thecapacity of the server.

Security and Reliability

The SaaS platforms put a lot of time and effort in the security and reliability of the system. These security standards are at least on the same level and regularly higher than most on-premise servers. Due to the infrastructure of these platforms, they have big incentives to keep the platform secure and reliable. Security and reliability shouldn’t be a reason to move to SaaS any-more. The infrastructure of the major data centers allows these platforms to have new serversalmost instantly.

Ease of Use

Enabling people to really add value to the management system can only be accomplished whenthe solution is easy to use. The employees have to have access to the platform from anywhere in the world and with any device. These characteristics are critical when you want to reach massadoption among the employees.

Integrate with Business Intelligence Tools

Most SaaS solutions come with API’s to easily integrate with other solutions like BI tools. The data has to be structured in such a way that the other solutions can interpret the information. The API is the unified way to accomplish this. When selecting your next solution, make sure the solution has an API to connect to.

Conclusion

There are a number of important points to look at, but when selecting a new Quality Management solution make sure you start to move towards a SaaS solution.

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The Impact of Poor Quality on Organizations as shown by Boeing

Boeing is facing big challenges these days. You bring a new product to the market and suddenly this seems to be the cause of several flight accidents. Since then, all the airplanes are grounded and the impact is huge, not only for Boeing, but also for the airlines.

This example clearly shows what a tremendous impact, a lack of quality can have on an organization. This can range from inefficiencies to lower customer satisfaction and even plain legal issues. As well as how important it is to invest in good quality control to prevent issues from happening. Hence, we use this article to highlight three possible effects, on how poor quality can affect your organization. 

Influencing Customer Satisfaction

Poor-quality products and services can have a significant impact on customer satisfaction. Such products and services cause a business to lose customers faster than they can gain new ones. In Boeing’s case, the crash will result in lower customer satisfaction because many countries around the world, have banned the 737 MAX from their airspace. The airlines aren’t allowed to use these plains anymore which will have some serious financial impact. Boeing’s product failed to meet customer expectations, which harms the company and the brand. Therefore, losing potentially business and revenue. 

Impact on Company’s Profitability

Poor quality can have a significant impact on a company’s profitability. This could be a lack of quality in human, physical, financial or knowledge factors that are needed to perform business processes. Boeing for example, delivered a product that was not up to mark, which will lead to significant costs. All the errors needs to be fixed, this leads to unbillable hours and delivering free components. These recalls have significant impact on the brand on the long term and on the profitability in the short term. An efficient and high-quality QMS platform can help prevent this in the future. Patterns can be analyzed and errors can be reduced.

Also all the financial litigations after the fact will have some serious impact on the bottomline of Boeing. There will be legal cases by airlines due to diminished revenue potential. The costs for this problem will be very high.

Causing Problems with Productivity

Poor quality costs a company a significant amount of money in terms of productivity problems. If quality is not a proactive measure, employees will spend their time on inefficient process and fixing incidents on a regular basis. It is crucial to find out which processes are inefficient and how to improve them. A correctly implemented QMS platform enables quality managers to access real-time productivity information, in terms of errors or incidents. With this information you can look for smarter, more efficient processes to get to the same goal and boosts productivity.

The solution

Investing in proper quality control is key to reduce poor quality. An effective QMS platform can help you to collect data and perform analyzes. Therefore, increasing the quality of your products and services over the long term. Ultimately, the cost of working with an ineffective system are exponentially higher than the cost of working with a proper quality management platform. Now let’s take a closer look at the benefits of a good quality management platform.

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The 7 Essential Quality Tools for Process Improvement

The 7 basic tools of quality (or 7 QC Tools) were conceptualized for the first time by Kaoru Ishikawa, a professor of engineering at the University of Tokyo. They are a set of relativity simple data analysis tools used to support quality improvement efforts.

The 7 basic quality tools are essentially techniques used to identify and fix issues related to product or process quality. When an organization starts the journey of quality improvement, they normally have many low hanging fruits. These could be eliminated with these basic 7 QC tools. The 7 QC tools are fairly simple to understand and implement because they don’t require complex analytical/ statistics to use.

So What Are the 7 Basic Tools of Quality?

  1. Control chart
  2. Flow Chart
  3. Check Sheet
  4. Pareto Chart
  5. Fishbone Diagram
  6. Histogram
  7. Scatter Diagram

Flow Chart

Flow charts are the best process improvement tools that you can use to analyze a series of events. They show you how processes work visually. This tool is mainly used to map out processes to determine where the bottlenecks or breakdowns are in work processes.

Cause and Effect Diagram

The cause-and-effect diagrams can be used to understand the root causes of business problems. This analysis is designed to get into the detailed fundamental causes of the issue, without any bias. The analysis will lead to significant insight into why thingswent wrong.

Check Sheet

A check sheet is a structured, prepared form (document) for collecting and analyzing data to evaluate quality. For example, you can use a check sheet to track the number of times a specific incident occurs.

Histogram

A histogram is a chart that shows how often a value, or range of value, occurswithin a given time period. Histograms provide a visual summary of a large amount of variable data. If the histogram is normal then the graph will have a bell-shaped curve.

Pareto Chart

Pareto charts are charts that contain bars and a line graph. A Pareto chart takes advantage of the 80/20 rule to visually show the categories with the largest impact on a problem. It states that 80 percent of an effect comes from 20 percent of the causes.

Control Chart

A control chart is a graph that displays trends, shifts, or patterns in the output ofa process over time. These charts allow you to identify the stability and predictability of the process and identify whether the process is under control.

Scatter Diagram

A scatter diagram or scatter plot is basically a statistical tool to represent the value of two different variables. The purpose of using this is to find the relationship between the problem (overall effect) and causes that are affecting.

Once a tool is learned, it can be adapted to various problem-solving opportunities. As with everything else, the use of these tools will require some practice and experience. Simply start with the tool that is easiest for you, and over time you will get the hang of it and become a great problem solver!

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6 Key Features Every Quality Management Platform Must Have

Considering a quality management platform for your organization? You’re not alone. Selecting the one that fits your company isn’t easy. Which features are needed to support your processes? How complex does it need to be? Is it user-friendly and intuitive enough for the employees? These are just some questions that you will need to answer during the selection process. In this blog, we discuss six key functionalities that your QM platform must have to support the basics of your QMS.

Automation

The single most important feature of an online platform is the automation. It has to save you and the company a lot of time. Automated notifications can help with staying compliant and reminding people of the areas to focus on. Make sure you come up with these triggers yourself to ensure they work for you and not against you.

Risk Analysis

Managing risks is critical for a proper QMS and at the bare minimum a hard requirement for compliance to the standard. A good quality management platform helps you to list your risks and connect the required actions. The connection between the risks and the actions will give great benefits. Make sure the platform is flexible enough to support multiple Risk Analysis methodologies such as FMEA or Fine & Kinney.

Action Planning

CAPA or action management is the lifeline of your management system. The action list shows how the company improves over time and which steps are taken to prevent issues from occurring in the future. The list can get quite extensive so make sure the interface has enough filters that allow you to find the most important actions that the company is working on.

Non-Conformance Reports / Issues

Another must-have is non-conformance reports (NCR). A lot of analytical data is stored in the non-conformities that happen in the company. A mobile app is a big differentiator for the team. The employees can now easily file an NCR by snapping a picture. When checking for the right solution, always check the analyze features. Running your own custom analysis in the platform will make life so much easier. The flexibility is key, don’t go for pre-defined options—they will become too limited very soon.

Audits and Inspections

Audits are where you can check how the management system functions. A clear interface will save a lot of time. The platform should allow you to have all the information in one screen, like your processes, NC reporting, and the ability to assign points of improvement and other tasks. The inspections are where you can easily make a check on your mobile phone. The inspection should be done on the mobile to save significant reporting time.

Document Management

Effective documentation is important for a well-functioning quality management platform, and every system should have it. Even though it is not required anymore, storing historical information is good for future reference.  With the right document management, you never risk having outdated procedures or work instructions. The system should take care of version control, and make them easily accessible to all

Show me 

Quality management is more than compliance or cost avoidance, it is about making real value out of your quality management system and make it part of your organizational culture. With a quality management platform that supports the above features you come along way with creating real value.

If you want to know how Qooling can help you. Please contact us!

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The Truth about QMS platforms vs. alternatives

It remains a bottleneck for many companies—do we opt for a quality management system or do we prefer one of the many alternatives? All solutions have their strengths, but they aren’t always the right solution to stay compliant and get the most out of your quality management. To give you a better insight into the bad and good sides of these solutions, we will shortly discuss the most common alternatives. 

Paper-Based Systems (Supported by Excel/Word)

Many companies still have a paper-based QMS system in combination with Word, Excel, and other Microsoft Office files to keep track of their documentation. The problem in a paper-based system is that companies constantly battle to make sure they are up-to-date with the latest procedures, copies, and more. Such systems require a lot of maintenance and are time-consuming to administer, which does not favor the benefits of a certificate. This approach also has a lot of time-consuming activities such as keying over the information from paper to Excel sheets. This not only costs a lot of time but also introduces lots of errors.

ERP Solutions

The use of ERP “solutions” for QMS has the potential to minimize the number of IT systems and offers “special” modules for certain aspects within QHSE compliance management. However, the fact is these systems are not built to be used as a compliance platform and certainly do not favor the functionality, flexibility, and support of a specialist system. These solutions can work for you, but they come at a cost of missing features and functionalities.

In-House Development

Of course, it is possible to develop a complete management system in-house. Choosing this route is usually the most expensive one. Not only does it cost scarce resources of developers, but it also requires a lot of input from operations. The developers have no idea what to develop. This needs to be analyzed and clarified by the people in the operations. When they help out, they cannot do their own job so the cost gets doubled. An other downside is the requirements of updates. Every time something needs to change the developers need to be available. This will lead to some serious costs to the company.

Specialized QMS System

A specialized QMS system such as Qooling provides the right tools to improve your business so that you can make decisions based on data from within your organization. These platforms are continuously improved based on feedback from customers and other specialists in the field. The updates are part of the package and don’t require additional costs. The fact that these platforms are built for compliance only, means that all the features are present and all aspects from different standards are embedded. The other big plus is that they run out of the box, which leads to an implementation time of weeks, not quarters or even years.

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